Medicines Act 1968

112 Power to inspect, take samples and seize goods and documents. U.K.

(1) For the purpose of ascertaining whether there is or has been a contravention of this Act or of any regulations or order made thereunder which, by or under any provisions of sections 108 to 110 of this Act an enforcement authority is required or empowered to enforce, any person duly authorised in writing by that authority shall have a right to inspect—

(a) any substance or article appearing to him to be a medicinal product;

(b) any article appearing to him to be a container or package used or intended to be used to contain any medicinal product or to be a label or leaflet used or intended to be used in connection with a medicinal product; or

(c) any plant or equipment appearing to him to be used or intended to be used in connection with the manufacture or assembly of medicinal products, and any process of manufacture or assembly of any medicinal products and the means employed, at any stage in the processes of manufacture or assembly, for testing the materials after they have been subjected to those processes.

(2) Where for the purpose specified in the preceding subsection a person authorised as mentioned in that subsection requires a sample of any substance or article appearing to him to be—

(a) a medicinal product sold or supplied or intended to be sold or supplied, or

(b) a substance or article used or intended to be used in the manufacture of a medicinal product,

he shall (if he does not obtain the sample by purchase) have a right to take a sample of that substance or article.

(3) For the purpose specified in subsection (1) of this section, any person authorised as mentioned in that subsection shall have a right—

(a) to require any person carrying on a business which consists of or includes the manufacture, assembly, sale or supply of medicinal products, and any person employed in connection with such a business, to produce any books or documents relating to the business which are in his possession or under his control;

(b) to take copies of, or of any entry in, any book or document produced in pursuance of the preceding paragraph.

(4) Any person so authorised shall have a right to seize and detain any substance or article which he has reasonable cause to believe to be a substance or article in relation to which, or by means of which, an offence under this Act is being or has been committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under this Act.

(5) For the purpose of exercising any such right as is specified in subsection (4) of this section the person having that right may, so far as is reasonably necessary in order to secure that the provisions of this Act and any regulations or order made thereunder are duly observed, require any person having authority to do so to break open any container or package or open any vending machine, or to permit him to do so.

(6) Where a person seizes any substance or article (including any document) in the exercise of such a right as is specified in subsection (4) of this section, he shall inform the person from whom it is seized, and, in the case of anything seized from a vending machine, the person whose name and address are stated on the machine as being those of the owner of the machine, or, if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed.

F1 (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) Notwithstanding anything in the preceding provisions of this section, where a person claiming to exercise a right by virtue of this section is required to produce his credentials, the right shall not be exercisable by him except on production of those credentials.

(9) The provisions of Schedule 3 to this Act shall have effect with respect to samples obtained on behalf of enforcement authorities for the purposes of this Act.

Textual Amendments

F1 S. 112(7) repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)

Modifications etc. (not altering text)

C1 Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

C2 S. 112 modified by S.I. 1985/273, reg. 2, Sch. 1 Pt. I

C3 S. 112 restricted by S.I. 1985/273, reg. 3(3)

C4 S. 112 modified (30.1.1992) by S.I. 1992/32, reg. 12(1)(2)

S. 112 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

S. 112 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 112 applied (with modifications) (1.1.1994) by S.I. 1994/3144, reg.10, Sch. 4

S. 112 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

S. 112 (other than s. 112(7)) applied (1.2.2000) by S.I. 2000/7, reg. 5

C5 Ss. 108-114 applied (with modifications) (1.7.1992) by S.I. 1992/1520, reg.12.

C6 Ss. 108-115 modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3

Ss. 108-115 applied (3.10.1994) by S.I. 1994/2328, reg. 11(c)

C7 Ss. 107-116 applied (with modifications) (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), regs. 1, 47, Schs. 9

C8 Ss. 111-116 applied (with modifications) (30.10.2005) by Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750) , regs. 1(a) , 11 , Schs. 4 (with Sch. 6 )

C9 Ss. 107-116 amendment to earlier affecting provision SI 2004/1031 reg. 47 Sch. 9 (29.8.2006) by Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 32